An increasing number of drug candidates made in China have been out-licensed. Here are the ones aimed for approval in foreign countries.
★ BL-B01D1, anti-EGFRxHER3 ADC, SystImmune
2023.12 Announced in Ph3, BMS
"$800 million in an upfront payment and up to $500 million in contingent near-term payments. SystImmune is eligible to receive additional payments of up to $7.1 billion contingent upon the achievement of certain development, regulatory and sales performance milestones for a total potential consideration of up to $8.4 billion. The companies will share certain global development expenses and profits and losses in the United States. Through its affiliates, SystImmune will retain exclusive development and commercialization rights in Mainland China, where Bristol Myers Squibb will receive a royalty on net sales. Outside the United States and Mainland China, SystImmune will receive a tiered royalty on net sales. The agreement is subject to customary clearance by antitrust regulators.
★ Tislelizumab, anti-PD-1 antibody, Beigene
2017.08 Announced in Ph3, Celgene, Terminated before approval in 2019.06
"An aggregate of $413 million from Celgene in upfront licensing fees and equity investment, and will be eligible for up to an additional $980 million in development, regulatory, and sales milestones, as well as royalties on future sales of BGB-A317.
2021.01 Announced after the Approval, Novartis, Terminated before approval in 2023.09, Approved in EU in 2023.09
"An upfront cash payment of $650 million from Novartis. BeiGene is eligible to receive up to $1.3 billion upon the achievement of regulatory milestones, $250 million upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory.
★ Ivonescimab, anti-VEGF/PD-1, Akeso
2022.12 Announced after the Approval, Summit
"US$500 million upfront payment and the total potential deal value is up to US$5 billion including regulatory and commercial milestone payments. And Akeso will also receive low double-digit percentage of royalties on net product sales of ivonescimab .The Summit will receive the exclusive rights to develop and commercialize ivonescimab (SMT112) in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the world including China.
★ Fruquintinib, VEGFR inhibitor, HUTCHMED
2023.01 Announced after the Approval, Takeda, Approved in US in 2023.11
"US$400 million upfront on closing of the agreement, and up to US$730 million in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sales.
★ Ciltacabtagene autoleucel, anti-BCMA CAR-T, Legend
2017.12 Announced in Ph1, Janssen, Approved in US in 2022.02
"The companies have entered into a 50/50 percent cost-sharing/profit-split arrangement, except in Greater China, where Janssen and Legend have a 30/70 percent cost-sharing/profit-split arrangement. Janssen will make an upfront payment of $350 million that will be recorded in the fourth quarter and additional payments based upon the achievement of certain development, regulatory and sales milestones.
★ Ociperlimab, anti-TIGIT antibody, Beigene
2021.12 Announced in Ph3, Novartis, Terminated in 2023.07
"An upfront payment to BeiGene of USD 300 million. A fee of up to USD 700 million would be paid to BeiGene if the option is exercised before late 2023. Upon exercise of the option, Novartis would obtain the development and commercialization rights to ociperlimab in the United States, Canada, Mexico, the European Union, United Kingdom, Norway, Iceland, Liechtenstein, Switzerland, Russia and Japan. BeiGene agrees to provide 50 percent of the co-detailing efforts in the United States following approval and will retain the rights to ociperlimab in China and all other countries.
★ C-CAR039, anti-CD19/CD20 CDR-T, Cellular Biomedicine
2023.05 Announced in Ph1b, Janssen
"An upfront payment of $245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon the achievement of certain development, regulatory and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China.
★ Sintilimab, anti-PD-1 antibody, Innovent
2020.08 Announced after the Approval, Lilly, CRL in 2022.03
"An upfront payment of $200 million and will be eligible for up to $825 million in potential development and commercial milestones, as well as tiered double-digit royalties on net sales. Both companies will also retain the right to study TYVYT in combination with other medicines as part of their own clinical programs.
★ Disitamab Vedotin, anti-HER2 ADC, Remegen
2021.09 Announced after the Approval, Remegen
"A $200 million upfront payment to exclusively license rights to disitamab vedotin for global development and commercialization, outside of RemeGen’s territory. RemeGen will retain development and commercialization rights for Asia, excluding Japan and Singapore. Seagen will lead global development and RemeGen will fund and operationalize the portion of global clinical trials attributable to its territory. RemeGen will also be responsible for all clinical development and regulatory submissions specific to its territory.
★ ECC5004, GLP-1R agonist, Eccogene
2023.11 Announced in Ph1, AstraZeneca
"An initial upfront payment of $185m. In addition, Eccogene will also receive up to an additional $1.825bn in future clinical, regulatory, and commercial milestones and tiered royalties on product net sales.
★ Two Undisclosed Programs, RNAi therapeutics, Argo Biopharma
2024.01 Announced in Ph1, Novartis
"upfront payments of $185 million from Novartis and is eligible to receive potential option and milestone payments as well as tiered royalties on commercial sales.
★ Lemzoparlimab, anti-CD47 antibody, I-Mab
2020.09 Announced in Ph1/2a, AbbVie, Terminated in 2020.09
"$180 million in an upfront payment to exclusively license lemzoparlimab, along with $20 million in a milestone payment based on the Phase 1 results, for a total of $200 million. In addition, I-Mab will be eligible to receive up to $1.74 billion in success-based milestone payments for lemzoparlimab, of which $840 million are based on clinical development and regulatory approval milestones, with the remainder based on commercial milestones. Upon commercialization of lemzoparlimab, AbbVie will also pay tiered royalties from low-to-mid teen percentages on global net sales outside of greater China.
★ DB-1303, anti-HER2 ADC, DualityBio
2023.04 Announced in Ph1/2a, BioNTech
"Upfront payments for both asset licenses totaling $170 million, and additional development, regulatory and commercial milestone payments for both assets, potentially totaling over $1.5 billion. DualityBio will be eligible to receive single-digit to double-digit tiered royalties on net sales for both ADC assets. BioNTech will hold commercial rights globally (excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region), while DualityBio will retain commercial rights for Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region. As part of the agreement for DB-1311, DualityBio has the right to exercise a co-development cost and profit/loss sharing option for DB-1311 for the U.S. market, as well as a co-promotion option for the U.S. market.
★ HRS-1167, PARP1 inhibitor, Hengrui
2023.10 Announced in Ph1, Merck KGaA
"An upfront payment of €160 million. Hengrui Pharma will receive payments for technology transfer as well as an option exercise for the Claudin-18.2 ADC for up to €90 million. Upon the achievement of certain development, regulatory and commercial milestones, Hengrui is eligible to receive royalty payments on net sales of such products by Merck KGaA, Darmstadt, Germany. Potential payments may total up to €1.4 billion with up to double-digit royalty payments.
★ Toripalimab, anti-PD-L1 antibody, Junshi
2021.12 Announced in Ph3, Coherus, Approval in US in 2023.10
"$150 million upfront for exclusive rights to toripalimab in the United States and Canada, options in these territories to Junshi Biosciences’ anti-TIGIT antibody and next-generation engineered IL-2 cytokine, and certain negotiation rights to two undisclosed preclinical immuno-oncology drug candidates. Coherus will also pay Junshi Biosciences a 20% royalty on net sales of toripalimab and up to an aggregate $380 million in one-time payments for the achievement of various milestones, including up to $290 million for attainment of certain sales thresholds.
★ Sugemalimab, anti-PD-L1 antibody, Cstone
2020.10 Announced in Ph3, ERQx, Terminated in 2023.05
"An upfront payment of US$150 million and up to US$1.15 billion in milestone payments for both drugs as well as separate tiered royalties. EQRx will obtain exclusive rights to lead global development and commercialization worldwide, excluding Mainland China, Taiwan, Hong Kong and Macau. CStone retains rights to CS1003 in Greater China, where it can continue to pursue development as a monotherapy or as part of its combination strategy for this drug.
★ Orelabrutinib, BTK inhibitor, Innocare
2021.07 Announced in Ph2, Biogen, Terminated in 2023.02
"A $125 million upfront payment and is eligible to receive up to $812.5 million in potential development milestones and potential commercial payments should the collaboration achieve certain development, commercial milestones and sales thresholds. InnoCare is also eligible to receive tiered royalties in the low to high teens on potential future net sales of any product resulting from the collaboration.
★ LB2102, anti-DLL3 CAR-T, Legend
2023.11 Announced in Ph1, Novartis
"A $100 million upfront payment and will be eligible to receive up to $1.01 billion in clinical, regulatory and commercial milestone payments and tiered royalties.
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